- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and immune disorders. SummaryThis new role is within R&D reporting into Global Clinical Operations (GCO) and the fundamental responsibility is dedicated to GCO. This ... the successful delivery of study diversity plans in adherence with Good Clinical Practices (GCPs), appropriate Standard Operating Procedures (SOPs), Food and Drug… more
- Insmed Incorporated (San Diego, CA)
- …of clinical studies milestones to support company budgets, and quality standards.Ensure the clinical department follows appropriate guidelines as it ... development of systems, practices, and procedures to ensure efficient and effective clinical trial execution including data management and analysis .Build and… more
- Merck & Co. (North Wales, PA)
- …technical or other potential problems arising in the design, conduct, and analysis of clinical trials, proposes solutions and carries them out.Develops ... to ensure that the data evaluated are in high quality and satisfy analysis requirements.May lead a...individual investigators.Provides responses to queries relating to study design, analysis , and interpretation posed by the clinical … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …payer evidence, economic models, and Global Value Dossiers- Propose and implement analysis of clinical trial data for cost effectiveness models and market ... including the implementation of global health economic models, global value dossiers, RWE studies, PRO analysis , and...key and visible expert leader, he/she will engage the clinical , Medical Affairs and commercial organization and drive the… more
- Merck & Co. (North Wales, PA)
- …This position supports statistical programming activities for late stage drug/vaccine clinical development projects. This may include leadership of one or more ... Accountability predominantly includes the development and execution of statistical analysis and reporting deliverables (eg safety and efficacy analysis… more
- Merck & Co. (North Wales, PA)
- Job DescriptionResponsibilities :This position provides high quality statistical programming analysis and reporting deliverables for global PK modeling and ... members when opportunities arise. Primary Activities :Programmatically synthesize preclinical / clinical data into analysis ready structures from varied data… more
- Merck & Co. (North Wales, PA)
- …programming activities for multiple and/or late stage drug/vaccine clinical development projects. -Accountability predominantly includes the development and ... execution of statistical analysis and reporting deliverables (eg safety and efficacy ...listings, figures), the span of which range from individual clinical trials to world-wide regulatory application submissions and post… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …all aspects of vendor management for assigned trials, effectively negotiates third party clinical contracts in adherence to Fair Market Value and internal ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...find better and more innovative ways to improve their quality of life. We're changing lives for a living.… more
- Merck & Co. (North Wales, PA)
- …data standards CDISC Study Data Tabulation Model (SDTM)Experience in SAS and clinical programmingKnowledge and experience in developing analysis and reporting ... project management skillsDemonstrated success in the assurance of deliverable quality and process complianceFamiliarity with statistical and clinical … more
- Merck & Co. (North Wales, PA)
- …a key collaborator with internal and external stakeholders including Statistics, Clinical Research, Regulatory, Observational Research, Clinical Safety and PK/PD ... operational challenges that require strategic solutions, resulting in improved Clinical Study Report and filing completion timelines worldwide.Lead development of… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …global project teams. This role will be a senior member of the Regulatory, Quality and Clinical Reporting (RQC) team, and will provide mentorship and coaching ... MA and Plainsboro, NJ. We support programs from early research through late-stage clinical development. We are building for the future, creating a distinct R&D… more
- Merck & Co. (Rahway, NJ)
- …data management concepts; CDISC and ADaM standards; process compliance and deliverable quality ; and developing analysis and reporting deliverables for Research ... Job DescriptionResponsibilities:Support statistical programming activities for clinical development projects.This may include leadership of one or more… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and execution of analyses; Provide guidance of the proper interpretation of statistical analysis results; Review or co-author the value dossier and scientific ... manage, with limited direction, Biostatistics study activities assigned and ensure high quality deliverables are on time and within budget. The position may also… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and develop insights to drive growth and operational excellence across the value chain while innovating for future capabilities. Our focus on innovation ensures ... decisions and drive organizational action, guide the Business units and the Clinical , Medical, and Regulatory Affairs (CMR) teams on strategy development and… more
- Lundbeck (Bothell, WA)
- …to determine the potency of drug product for early through late-stage clinical development programs. The successful candidate will have a thorough understanding of ... role will interact with Lundbeck Seattle Upstream, Downstream, Formulation, and Quality Control groups so strong interpersonal skills will be beneficial. ESSENTIAL… more
- Providence (Everett, WA)
- …Team, the CNO leads in the planning, implementation, monitoring, and evaluation of the quality of clinical care across the full clinical care continuum. ... system and regional colleagues to achieve system and regional quality outcomes, and priority strategic clinical initiatives....the good of the whole. Develops and maximizes the value of talent through robust workforce development strategies to… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... find better and more innovative ways to improve their quality of life. We're changing lives for a living....sub-team. The HEOR-ESS sub-team is part of a larger Clinical Data Science and Evidence (CDSE) team within the… more
- Tufts Medical Center (Boston, MA)
- …initiatives. 13. Participates in performance improvement activities through data collection, analysis and evaluation. 14. Champions quality , safety, regulatory, ... with physician orders. In addition, this role focuses on performing the following Clinical Nurse duties: Assesses, plans, implements, and evaluates the care needs of… more
- Tufts Medical Center (Boston, MA)
- …safety initiativesParticipates in performance improvement activities through data collection, analysis and evaluationChampion for quality , safety, regulatory, ... credential a health care organization can achieve for nursing excellence and quality patient care. Magnet(R) recognition signals to nurses that the organization is… more
- Merck & Co. (South San Francisco, CA)
- …Experience and Skills:Experience in leading bioconjugate programs to deliver high quality clinical candidatesExperience in mentoring and training junior ... research conducted in our new laboratories spans exploratory biology through early clinical development and is an integral part of our Comp's powerful world-class… more
